Regulatory Affairs Manager II

100% Remote (EST time zone)
Regulatory Affairs Manager II
12 months+
Pay Range $65-$68/hr on w2

Chat Note: Regulatory Systems Expertise, eCTD Submission Management, Collaboration: Working with global IT and cross-functional teams to implement systems, Quality Control Process, Documentation & Testing.

Should have Regulatory Submission & eCTD publishing experience
Must have Highlighted skills in InSight, Veeva

Skills:

1. Regulatory Systems experience (ie, InSight, Veeva, Docubridge, CARA) and submissions process knowledge is essential.
2. Experience with drafting and review of process documents, mapping, SOW documentation, and UAT testing.
3. Experience of working closely with global IT and cross functional stakeholders to implement training and support to end users for new systems, tools and applications.
4. Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations.

3-5 years of experience in regulatory operations with experience in Regulatory systems and submissions.

Submissions support:
Performs eCTD submission management across ***'s product portfolio to Health Authorities for global development and lifecycle management submissions.
Oversee outsourced publishing deliverables to ensure successful execution of operational activities for assigned products.
Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Responsible for electronic submissions and documents meeting regulatory agency and *** submission standards and technical requirements. Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines.
Competent in the use of electronic document management and submissions publishing tools.